Associate Scientist

Job Description

Job Summary:

• The Assistant/Associate Scientist/Engineer to join our Vector and Gene Delivery MS&T group in GDPAD.
• The successful candidate will design and execute experiments related to supporting commercial vector manufacturing processes.
• This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

Duties and Responsibilities:

• Oversee lab activities and schedule.
• Design studies to support commercial manufacturing deviation investigations.
• Support the the execution of process characterization studies.
• Collaborate with commercial vector team to identify opportunities for process improvements, make formal recommendations.
• Lead identification and implementation of new technologies and procedures from Development into Manufacturing.
• Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites.
• Support the hands-on training of commercial process unit operations to Vector MS&T.
• Identify, design and manage small capital engineering projects.

Education/Experience/ Licenses/Certifications:

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing.
• Preference given to candidates with experience performing process characterization.
• Knowledge of cellular immunology and/or vector manufacturing a plus.
• Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organization.
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab).
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Experience writing experimental plans and protocols.

Knowledge, Skills and Abilities:

• The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
• Experience should include management of lab activities, technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, and process characterization.
• Prefer experience with leading experiments and designing DOEs.
• Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment preferred.
• Prior experience with SOPs, cGMPs and how they are applied within a regulatory environment required.
• Prior experience participating in process characterization preferred.

Physical Demands:

• Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs.
• Occasional bending, twisting and stooping to allow for gowning into classified environment required.

Work Environment:

• Position will require time in the office and lab.
• Position is a team & project-based position that will require occasional shift work, weekends, and holidays.

Additional Job Requirements:

• Lab w/o blood & animal.
• Position Handles Hazardous Materials.